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FDA 510(k)

ArtiFascia

K 號:K223445 · 2023-08-10

決定日期2023-08-10
產品代碼GXQ
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

ArtiFascia is the device name listed in this FDA 510(k) record. The listed applicant is Nurami Medical , Ltd.. It received FDA 510(k) clearance on 2023-08-10 under 510(k) number K223445. The device is classified under product code GXQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the ArtiFascia?

ArtiFascia is a medical device that received FDA 510(k) clearance on 2023-08-10. The listed applicant is Nurami Medical , Ltd.. The 510(k) number is K223445.

When did ArtiFascia receive FDA 510(k) clearance?

ArtiFascia received FDA 510(k) clearance on 2023-08-10, under 510(k) number K223445.

Who is the listed applicant for ArtiFascia?

The FDA 510(k) record lists Nurami Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArtiFascia?

The FDA product code for ArtiFascia is GXQ.

相關臨床試驗

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相關器械(代碼:GXQ)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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